Trial Outcomes & Findings for A Study in India on the Immune Response and Safety of a Respiratory Syncytial Virus (RSV) Older Adults (OA) Vaccine When Given to Older Adults 60 Years of Age and Above and Adults 50-59 Years of Age at Increased Risk (AIR) of Respiratory Syncytial Virus Lower Respiratory Tract Disease (RSV-LRTD) (NCT NCT06614725)
NCT ID: NCT06614725
Last Updated: 2026-06-23
Results Overview
RSV-A neutralizing titers are given as GMTs and are expressed as Estimated Dilution 60 (ED60).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
751 participants
Primary outcome timeframe
At Day 1 (pre-study intervention administration)
Results posted on
2026-06-23
Participant Flow
Out of 751 participants enrolled, 750 received the study intervention (RSVPreF3 OA investigational vaccine or placebo) and were included in the Exposed Set.
Participant milestones
| Measure |
OA-RSV Group
Older adult (OA) participants, greater than or equal to (≥) 60 years of age (YOA), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
OA-Placebo Group
OA participants, ≥ 60 YOA, received a single dose of placebo at Day 1.
|
Adults-AIR-RSV Group
Adult participants, 50-59 YOA, at increased risk (AIR) of Respiratory Syncytial Virus - Lower Respiratory Tract Disease (RSV-LRTD), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
Adults-AIR-Placebo Group
Adult participants, 50-59 YOA, at increased risk (AIR) of RSV-LRTD, received a single dose of placebo at Day 1.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
260
|
130
|
240
|
120
|
|
Overall Study
COMPLETED
|
259
|
129
|
240
|
119
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
OA-RSV Group
Older adult (OA) participants, greater than or equal to (≥) 60 years of age (YOA), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
OA-Placebo Group
OA participants, ≥ 60 YOA, received a single dose of placebo at Day 1.
|
Adults-AIR-RSV Group
Adult participants, 50-59 YOA, at increased risk (AIR) of Respiratory Syncytial Virus - Lower Respiratory Tract Disease (RSV-LRTD), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
Adults-AIR-Placebo Group
Adult participants, 50-59 YOA, at increased risk (AIR) of RSV-LRTD, received a single dose of placebo at Day 1.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
1
|
Baseline Characteristics
A Study in India on the Immune Response and Safety of a Respiratory Syncytial Virus (RSV) Older Adults (OA) Vaccine When Given to Older Adults 60 Years of Age and Above and Adults 50-59 Years of Age at Increased Risk (AIR) of Respiratory Syncytial Virus Lower Respiratory Tract Disease (RSV-LRTD)
Baseline characteristics by cohort
| Measure |
OA-RSV Group
n=260 Participants
Older adult (OA) participants, greater than or equal to (≥) 60 years of age (YOA), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
OA-Placebo Group
n=130 Participants
OA participants, ≥ 60 YOA, received a single dose of placebo at Day 1.
|
Adults-AIR-RSV Group
n=240 Participants
Adult participants, 50-59 YOA, at increased risk (AIR) of Respiratory Syncytial Virus - Lower Respiratory Tract Disease (RSV-LRTD), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
Adults-AIR-Placebo Group
n=120 Participants
Adult participants, 50-59 YOA, at increased risk (AIR) of RSV-LRTD, received a single dose of placebo at Day 1.
|
Total
n=750 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
69.7 YEARS
STANDARD_DEVIATION 6.7 • n=20 Participants
|
69.7 YEARS
STANDARD_DEVIATION 7.3 • n=20 Participants
|
54.5 YEARS
STANDARD_DEVIATION 2.8 • n=40 Participants
|
54.6 YEARS
STANDARD_DEVIATION 2.7 • n=5 Participants
|
62.4 YEARS
STANDARD_DEVIATION 9.3 • n=9 Participants
|
|
Sex: Female, Male
Female
|
93 Participants
n=20 Participants
|
39 Participants
n=20 Participants
|
99 Participants
n=40 Participants
|
47 Participants
n=5 Participants
|
278 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
167 Participants
n=20 Participants
|
91 Participants
n=20 Participants
|
141 Participants
n=40 Participants
|
73 Participants
n=5 Participants
|
472 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Asian
|
258 Participants
n=20 Participants
|
129 Participants
n=20 Participants
|
238 Participants
n=40 Participants
|
120 Participants
n=5 Participants
|
745 Participants
n=9 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
2 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: At Day 1 (pre-study intervention administration)Population: Analysis was performed on the per protocol set(PPS) for RSV-A which included all eligible participants who received the study intervention as per protocol,had RSV-A immunogenicity results pre- and post-dose, complied with blood draw intervals, without prohibited concomitant medication/vaccination and intercurrent conditions that may interfere with immunogenicity.Only participants included in pre-vaccination timepoint and with data available for RSV-A titers at Day1 were included in the analysis.
RSV-A neutralizing titers are given as GMTs and are expressed as Estimated Dilution 60 (ED60).
Outcome measures
| Measure |
OA-Placebo Group
n=129 Participants
OA participants, ≥ 60 YOA, received a single dose of placebo at Day 1.
|
Adults-AIR-RSV Group
n=239 Participants
Adult participants, 50-59 YOA, at increased risk (AIR) of Respiratory Syncytial Virus - Lower Respiratory Tract Disease (RSV-LRTD), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
Adults-AIR-Placebo Group
n=120 Participants
Adult participants, 50-59 YOA, at increased risk (AIR) of RSV-LRTD, received a single dose of placebo at Day 1.
|
OA-RSV Group
n=256 Participants
Older adult (OA) participants, greater than or equal to (≥) 60 years of age (YOA), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
|---|---|---|---|---|
|
RSV-A Neutralizing Titers Expressed as Geometric Mean Titers (GMTs)
|
1316.7 Titers
Interval 1123.3 to 1543.4
|
1255.0 Titers
Interval 1128.3 to 1395.9
|
1105.3 Titers
Interval 964.8 to 1266.3
|
1210.0 Titers
Interval 1096.6 to 1335.2
|
PRIMARY outcome
Timeframe: At Day 31 (1 month post-study intervention administration)Population: Analysis was performed on the PPS for RSV-A. Only participants included in both pre-vaccination and 1-month post vaccination timepoints and with data available for RSV-A titers at 1-month post dose were included in the analysis.
RSV-A neutralizing titers are given as GMTs and are expressed as ED60.
Outcome measures
| Measure |
OA-Placebo Group
n=122 Participants
OA participants, ≥ 60 YOA, received a single dose of placebo at Day 1.
|
Adults-AIR-RSV Group
n=234 Participants
Adult participants, 50-59 YOA, at increased risk (AIR) of Respiratory Syncytial Virus - Lower Respiratory Tract Disease (RSV-LRTD), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
Adults-AIR-Placebo Group
n=117 Participants
Adult participants, 50-59 YOA, at increased risk (AIR) of RSV-LRTD, received a single dose of placebo at Day 1.
|
OA-RSV Group
n=248 Participants
Older adult (OA) participants, greater than or equal to (≥) 60 years of age (YOA), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
|---|---|---|---|---|
|
RSV-A Neutralizing Titers Expressed as GMTs
|
1304.5 Titers
Interval 1109.6 to 1533.6
|
14982.7 Titers
Interval 13096.7 to 17140.4
|
1129.5 Titers
Interval 980.8 to 1300.7
|
10777.9 Titers
Interval 9475.5 to 12259.3
|
PRIMARY outcome
Timeframe: At Day 1 (pre-study intervention administration)Population: Analysis was performed on the per protocol set(PPS) for RSV-B which included all eligible participants who received the study intervention as per protocol,had RSV-B immunogenicity results pre- and post-dose, complied with blood draw intervals,without prohibited concomitant medication/vaccination and intercurrent conditions that may interfere with immunogenicity.Only participants included in pre-vaccination timepoint and with data available for RSV-B titers at Day1 were included in the analysis.
RSV-B neutralizing titers are given as GMTs and are expressed as ED60.
Outcome measures
| Measure |
OA-Placebo Group
n=129 Participants
OA participants, ≥ 60 YOA, received a single dose of placebo at Day 1.
|
Adults-AIR-RSV Group
n=239 Participants
Adult participants, 50-59 YOA, at increased risk (AIR) of Respiratory Syncytial Virus - Lower Respiratory Tract Disease (RSV-LRTD), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
Adults-AIR-Placebo Group
n=120 Participants
Adult participants, 50-59 YOA, at increased risk (AIR) of RSV-LRTD, received a single dose of placebo at Day 1.
|
OA-RSV Group
n=256 Participants
Older adult (OA) participants, greater than or equal to (≥) 60 years of age (YOA), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
|---|---|---|---|---|
|
RSV-B Neutralizing Titers Expressed as GMTs
|
1571.0 Titers
Interval 1348.9 to 1829.8
|
1579.1 Titers
Interval 1406.2 to 1773.3
|
1548.4 Titers
Interval 1323.6 to 1811.3
|
1561.3 Titers
Interval 1411.0 to 1727.6
|
PRIMARY outcome
Timeframe: At Day 31 (1 month post-study intervention administration)Population: Analysis was performed on the PPS for RSV-B. Only participants included in both pre-vaccination and 1-month post vaccination timepoints and with data available for RSV-B titers at 1-month post dose were included in the analysis.
RSV-B neutralizing titers are given as GMTs and are expressed as ED60.
Outcome measures
| Measure |
OA-Placebo Group
n=122 Participants
OA participants, ≥ 60 YOA, received a single dose of placebo at Day 1.
|
Adults-AIR-RSV Group
n=234 Participants
Adult participants, 50-59 YOA, at increased risk (AIR) of Respiratory Syncytial Virus - Lower Respiratory Tract Disease (RSV-LRTD), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
Adults-AIR-Placebo Group
n=117 Participants
Adult participants, 50-59 YOA, at increased risk (AIR) of RSV-LRTD, received a single dose of placebo at Day 1.
|
OA-RSV Group
n=248 Participants
Older adult (OA) participants, greater than or equal to (≥) 60 years of age (YOA), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
|---|---|---|---|---|
|
RSV-B Neutralizing Titers Expressed as GMTs
|
1721.1 Titers
Interval 1477.0 to 2005.6
|
15846.5 Titers
Interval 13910.4 to 18052.0
|
1398.4 Titers
Interval 1211.1 to 1614.6
|
11834.9 Titers
Interval 10560.7 to 13263.0
|
SECONDARY outcome
Timeframe: From Day 1 (day of administration) to Day 4Population: Analysis was performed on the Exposed Set, which included all participants who received the study intervention. Only participants with data available for solicited administration site events at the specified time period were included in the analysis.
Assessed solicited administration site adverse events (AEs) were redness (erythema), pain and swelling at administration site. Any = occurrence of the AE regardless of intensity grade or relationship to the study interventions.
Outcome measures
| Measure |
OA-Placebo Group
n=130 Participants
OA participants, ≥ 60 YOA, received a single dose of placebo at Day 1.
|
Adults-AIR-RSV Group
n=240 Participants
Adult participants, 50-59 YOA, at increased risk (AIR) of Respiratory Syncytial Virus - Lower Respiratory Tract Disease (RSV-LRTD), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
Adults-AIR-Placebo Group
n=120 Participants
Adult participants, 50-59 YOA, at increased risk (AIR) of RSV-LRTD, received a single dose of placebo at Day 1.
|
OA-RSV Group
n=260 Participants
Older adult (OA) participants, greater than or equal to (≥) 60 years of age (YOA), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
|---|---|---|---|---|
|
Number of Participants Reporting Any Solicited Administration Site Events
Erythema
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events
Swelling
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Any Solicited Administration Site Events
Pain
|
36 Participants
|
109 Participants
|
36 Participants
|
126 Participants
|
SECONDARY outcome
Timeframe: From Day 1 (day of administration) to Day 4Population: Analysis was performed on the Exposed Set. Only participants with data available for solicited systemic events at the specified time period were included in the analysis.
Assessed solicited systemic events were arthralgia (joint pain), fatigue (tiredness), fever (pyrexia), headache, and myalgia (muscle pain). Fever was defined as temperature ≥38.0 degrees Celsius (°C), regardless of the location of measurement. The route for measuring temperature could be oral or axillary. Any = occurrence of the symptom regardless of intensity grade or relationship to the study interventions.
Outcome measures
| Measure |
OA-Placebo Group
n=130 Participants
OA participants, ≥ 60 YOA, received a single dose of placebo at Day 1.
|
Adults-AIR-RSV Group
n=240 Participants
Adult participants, 50-59 YOA, at increased risk (AIR) of Respiratory Syncytial Virus - Lower Respiratory Tract Disease (RSV-LRTD), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
Adults-AIR-Placebo Group
n=120 Participants
Adult participants, 50-59 YOA, at increased risk (AIR) of RSV-LRTD, received a single dose of placebo at Day 1.
|
OA-RSV Group
n=260 Participants
Older adult (OA) participants, greater than or equal to (≥) 60 years of age (YOA), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
|---|---|---|---|---|
|
Number of Participants Reporting Any Solicited Systemic Events
Myalgia
|
11 Participants
|
33 Participants
|
2 Participants
|
17 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Arthralgia
|
4 Participants
|
12 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Fatigue
|
24 Participants
|
57 Participants
|
23 Participants
|
47 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Fever
|
5 Participants
|
17 Participants
|
8 Participants
|
13 Participants
|
|
Number of Participants Reporting Any Solicited Systemic Events
Headache
|
19 Participants
|
40 Participants
|
14 Participants
|
25 Participants
|
SECONDARY outcome
Timeframe: From Day 1 (day of administration) to Day 30Population: Analysis was performed on the Exposed Set. Only participants with data available for unsolicited events at the specified time period were included in the analysis.
An unsolicited AE was an AE that was either not included in the list of solicited events or could be included in the list of solicited events but with an onset outside the specified period of follow-up for solicited events. Unsolicited AEs included both serious and non-serious AEs, and potential immune-mediated diseases (pIMDs). Any = occurrence of the event regardless of intensity grade or relation to the study intervention.
Outcome measures
| Measure |
OA-Placebo Group
n=130 Participants
OA participants, ≥ 60 YOA, received a single dose of placebo at Day 1.
|
Adults-AIR-RSV Group
n=240 Participants
Adult participants, 50-59 YOA, at increased risk (AIR) of Respiratory Syncytial Virus - Lower Respiratory Tract Disease (RSV-LRTD), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
Adults-AIR-Placebo Group
n=120 Participants
Adult participants, 50-59 YOA, at increased risk (AIR) of RSV-LRTD, received a single dose of placebo at Day 1.
|
OA-RSV Group
n=260 Participants
Older adult (OA) participants, greater than or equal to (≥) 60 years of age (YOA), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
|---|---|---|---|---|
|
Number of Participants Reporting Any Unsolicited AEs
|
5 Participants
|
14 Participants
|
3 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: From Day 1 (day of administration) to Month 6 (throughout the study period)Population: Analysis was performed on the Exposed Set. Only participants with data available for SAEs at the specified time period were included in the analysis.
An SAE was any untoward medical occurrence that resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, was a congenital anomaly/birth defect in the offspring of a study participant, was considered or defined as an important medical event, or abnormal pregnancy outcomes. Any = occurrence of the event regardless of the intensity grade or relation to the study intervention.
Outcome measures
| Measure |
OA-Placebo Group
n=130 Participants
OA participants, ≥ 60 YOA, received a single dose of placebo at Day 1.
|
Adults-AIR-RSV Group
n=240 Participants
Adult participants, 50-59 YOA, at increased risk (AIR) of Respiratory Syncytial Virus - Lower Respiratory Tract Disease (RSV-LRTD), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
Adults-AIR-Placebo Group
n=120 Participants
Adult participants, 50-59 YOA, at increased risk (AIR) of RSV-LRTD, received a single dose of placebo at Day 1.
|
OA-RSV Group
n=260 Participants
Older adult (OA) participants, greater than or equal to (≥) 60 years of age (YOA), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
|---|---|---|---|---|
|
Number of Participants Reporting Any Serious Adverse Events (SAEs)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 1 (day of administration) to Month 6 (throughout the study period)Population: Analysis was performed on the Exposed Set. Only participants with data available for pIMDs at the specified time period were included in the analysis.
pIMDs were a subset of adverse events of special interest (AESIs) that included autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have had an autoimmune etiology. Any = occurrence of the event regardless of the intensity grade or relation to the study intervention.
Outcome measures
| Measure |
OA-Placebo Group
n=130 Participants
OA participants, ≥ 60 YOA, received a single dose of placebo at Day 1.
|
Adults-AIR-RSV Group
n=240 Participants
Adult participants, 50-59 YOA, at increased risk (AIR) of Respiratory Syncytial Virus - Lower Respiratory Tract Disease (RSV-LRTD), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
Adults-AIR-Placebo Group
n=120 Participants
Adult participants, 50-59 YOA, at increased risk (AIR) of RSV-LRTD, received a single dose of placebo at Day 1.
|
OA-RSV Group
n=260 Participants
Older adult (OA) participants, greater than or equal to (≥) 60 years of age (YOA), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
|---|---|---|---|---|
|
Number of Participants Reporting Any pIMDs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
OA-RSV Group
Serious events: 0 serious events
Other events: 154 other events
Deaths: 0 deaths
OA-Placebo Group
Serious events: 0 serious events
Other events: 64 other events
Deaths: 0 deaths
Adults-AIR-RSV Group
Serious events: 1 serious events
Other events: 141 other events
Deaths: 0 deaths
Adults-AIR-Placebo Group
Serious events: 0 serious events
Other events: 57 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
OA-RSV Group
n=260 participants at risk
Older adult (OA) participants, greater than or equal to (≥) 60 years of age (YOA), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
OA-Placebo Group
n=130 participants at risk
OA participants, ≥ 60 YOA, received a single dose of placebo at Day 1.
|
Adults-AIR-RSV Group
n=240 participants at risk
Adult participants, 50-59 YOA, at increased risk (AIR) of Respiratory Syncytial Virus - Lower Respiratory Tract Disease (RSV-LRTD), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
Adults-AIR-Placebo Group
n=120 participants at risk
Adult participants, 50-59 YOA, at increased risk (AIR) of RSV-LRTD, received a single dose of placebo at Day 1.
|
|---|---|---|---|---|
|
Infections and infestations
COVID-19
|
0.00%
0/260 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/130 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.42%
1/240 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/260 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/130 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.42%
1/240 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
Other adverse events
| Measure |
OA-RSV Group
n=260 participants at risk
Older adult (OA) participants, greater than or equal to (≥) 60 years of age (YOA), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
OA-Placebo Group
n=130 participants at risk
OA participants, ≥ 60 YOA, received a single dose of placebo at Day 1.
|
Adults-AIR-RSV Group
n=240 participants at risk
Adult participants, 50-59 YOA, at increased risk (AIR) of Respiratory Syncytial Virus - Lower Respiratory Tract Disease (RSV-LRTD), received a single dose of RSVPreF3 OA investigational vaccine at Day 1.
|
Adults-AIR-Placebo Group
n=120 participants at risk
Adult participants, 50-59 YOA, at increased risk (AIR) of RSV-LRTD, received a single dose of placebo at Day 1.
|
|---|---|---|---|---|
|
General disorders
Injection site pain
|
48.5%
126/260 • Number of events 126 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
27.7%
36/130 • Number of events 36 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
45.4%
109/240 • Number of events 109 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
30.0%
36/120 • Number of events 36 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
General disorders
Fatigue
|
18.1%
47/260 • Number of events 47 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
18.5%
24/130 • Number of events 24 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
23.8%
57/240 • Number of events 57 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
19.2%
23/120 • Number of events 23 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
General disorders
Pyrexia
|
5.4%
14/260 • Number of events 14 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
3.8%
5/130 • Number of events 5 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
7.5%
18/240 • Number of events 18 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
7.5%
9/120 • Number of events 9 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
General disorders
Asthenia
|
0.38%
1/260 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/130 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.42%
1/240 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
General disorders
Injection site swelling
|
0.38%
1/260 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/130 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.42%
1/240 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
General disorders
Pain
|
0.38%
1/260 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/130 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.42%
1/240 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
General disorders
Xerosis
|
0.38%
1/260 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/130 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/240 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Nervous system disorders
Headache
|
10.0%
26/260 • Number of events 26 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
15.4%
20/130 • Number of events 20 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
17.1%
41/240 • Number of events 42 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
12.5%
15/120 • Number of events 15 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/260 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/130 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.42%
1/240 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.5%
17/260 • Number of events 17 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
8.5%
11/130 • Number of events 11 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
13.8%
33/240 • Number of events 33 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
1.7%
2/120 • Number of events 2 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.5%
4/260 • Number of events 4 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
3.1%
4/130 • Number of events 4 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
5.0%
12/240 • Number of events 12 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
1.7%
2/120 • Number of events 2 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/260 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/130 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.42%
1/240 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Infections and infestations
Rhinitis
|
0.00%
0/260 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.77%
1/130 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/240 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/260 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/130 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.42%
1/240 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.77%
2/260 • Number of events 2 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.77%
1/130 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/240 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Infections and infestations
Lower respiratory tract infection
|
0.38%
1/260 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/130 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/240 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Infections and infestations
Body tinea
|
0.00%
0/260 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.77%
1/130 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/240 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/260 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.77%
1/130 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/240 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Infections and infestations
Viral infection
|
0.00%
0/260 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.77%
1/130 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/240 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/260 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/130 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.42%
1/240 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Infections and infestations
Tinea infection
|
0.00%
0/260 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/130 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.42%
1/240 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Infections and infestations
Bronchitis
|
0.38%
1/260 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/130 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/240 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Infections and infestations
Furuncle
|
0.38%
1/260 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/130 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/240 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Infections and infestations
Infective exacerbation of asthma
|
0.38%
1/260 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/130 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/240 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/260 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.77%
1/130 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.42%
1/240 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/260 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/130 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.83%
2/240 • Number of events 2 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/260 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/130 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/240 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.83%
1/120 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/260 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/130 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.42%
1/240 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/260 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/130 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.42%
1/240 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/260 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/130 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.42%
1/240 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.77%
2/260 • Number of events 2 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/130 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/240 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.38%
1/260 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/130 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/240 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/260 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.77%
1/130 • Number of events 1 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/240 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
0.00%
0/120 • Solicited AEs were collected from Day 1 (day of administration) up to Day 4 post-dose. Unsolicited AEs were collected from Day 1 up to Day 30 post-dose. All-cause mortality, SAEs, and pIMDs were collected throughout the study (from Day 1 to Month 6).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER